[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100384647":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":33,"responsibleParty":54,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":31,"eligibilityCriteria":65,"healthyVolunteers":62,"sex":66,"minAge":67,"maxAge":31,"enrollmentInfo":68,"targetDuration":31,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":84,"overallStatus":35,"whyStopped":31,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Beth Israel Deaconess Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Finasteride Treatment","EXPERIMENTAL","Patients who are eligible will be given 5ARI therapy, Finasteride, for medical management of Benign Prostatic Hyperplasia (BPH) symptoms. Only patients with lower urinary tract symptoms (LUTS) as assessed by American Urologic Association (AUA) urinary symptom score \\> than 8, (suggestive of moderate LUTS) prostate size \\> 40cc, no prostate nodule\u002Ftenderness\u002Ffirmness and increased PSA between 4-10ng\u002Fml requiring prostate biopsy will be enrolled. Then, they will have prostate MRIs\u002Fneedle biopsies and blood\u002Furine collection followed by treatment with Finasteride (standard of care). They will be followed in urology clinic for assessment of LUTS every 6 months and Finasteride responsiveness at the 12-month time point. Prostate biopsy samples will be evaluated for SRD5A2 gene expression\u002Fmethylation, hormonal androgen\u002Festrogen levels (which will be repeated in blood samples). Prostate MRIs will assess size\u002Finflammatory changes at the start and 3-year time points.",[13],"Drug: Finasteride",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Finasteride","Patients who are candidates to receive 5ARI therapy, Finasteride, for clinical medical management of lower urinary tract symptoms will begin treatment once deemed eligible. They will be assess every 6 months for changes in urinary symptom scores and their responsiveness to the Finasteride treatment will be assessed at the 12-month time point. MRIs of prostate taken at the start of study and at the 3 year time point will assess prostate size and changes in size as well as degree of inflammatory changes. Gene expression of SRD5A2 as well as methylation pattern will be tested on prostate tissue samples, where hormonal androgen\u002Festrogen levels will also be assessed as they are in blood samples.",[9],[21],"Sequential Time Point Study",[23],{"name":24,"affiliation":5,"role":25},"Aria F. Olumi, MD","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Yulia Mulugeta, BS","CONTACT","617-632-8890",null,"ymuluget@bidmc.harvard.edu",[34],{"facility":5,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Boston","Massachusetts","02215","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-71.05977,42.35843,{"lat":45,"lon":44},[48,52],{"name":49,"role":29,"phone":50,"phoneExt":31,"email":51},"Victoria Faustin, BA","617-632-1048","vfaustin@bidmc.harvard.edu",{"name":53,"role":25,"phone":31,"phoneExt":31,"email":31},"Aria Olumi, MD",{"type":25,"investigatorFullName":24,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Principal Investigator; Chief of Urologic Surgery at Beth Israel Deaconess Medical Center; Janet & William DeWolf Professor of Surgery\u002FUrology at Harvard Medical School; American Urological Association Chair of Research",[57],{"name":58,"class":59},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100384647","5-alpha-reductase-2-as-a-marker-of-resistance-to-5ari-therapy-100384647",false,"NCT04288427","5-Alpha Reductase 2 as a Marker of Resistance to 5ARI Therapy","Inclusion Criteria:\n\n* Male (physiological);\n* Age ≥ 50;\n* Eligible for treatment with 5ARI therapy;\n* Presence of lower urinary tract symptoms secondary to BPH;\n* Prostate size \\>40cc by digital rectal examination;\n* Absence of prostate nodule, tenderness or firmness;\n* Mildly elevated PSA's \\>1.5 ng\u002Fml and ≤ 40 ng\u002Fml;\n* Undergoing clinically indicated prostate biopsy for elevated prostate-specific antigen (PSA).\n\nExclusion Criteria:\n\n* Diagnosis of any prostatic malignancy or precancerous lesions (atypical glandular foci and prostatic intraepithelial neoplasia);\n* Treatment with 5ARI (Finasteride or Dutasteride) within six months of study enrollment;\n* Current urinary tract infection;\n* Previous pelvic radiation;\n* Previous treatment with demethylating drugs;\n* Diagnosis of multiple sclerosis, Alzheimer's, Parkinson's, neurological deficits in the judgment of the investigator;\n* Unable or unwilling to undergo MRI due to implants, claustrophobia, etc.","MALE","50 Years",{"count":69,"type":70},120,"ESTIMATED","INTERVENTIONAL",[73],"NA","The study is being conducted to learn why some patients with Benign Prostatic Hyperplasia (BPH) do not respond to a commonly used treatment drug, Finasteride. The hope is to find ways to predict which patients will not respond to Finasteride so that, in the future, these patients can be identified prior to offering this treatment and they can be offered alternative treatment strategies in its place. The aim is to see if noninvasive techniques such as MRI can detect inflammation of the prostate to assist with early detection of those who will and who will not respond to Finasteride.",[76,77,78,79,80,81,82,83],"Benign Prostatic Hyperplasia","Prostate Hyperplasia","Prostate Disease","Prostate Hypertrophy","Prostate Pain","Lower Urinary Tract Symptoms","Urinary Obstruction","Urinary Tract Disease",[17,85],"5 Alpha Reductase","2025-10-27",{"date":88,"type":89},"2025-10-28","ACTUAL",{"date":91,"type":89},"2020-09-25",{"date":93,"type":70},"2026-11-30",{"name":5,"class":6},1]